YY/T 0606.25-2014Tissue engineered medical product - Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method (English PDF)
组织工程医疗产品 第25部分 动物源性生物材料DNA残留量测定法：荧光染色法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0606.25-2014 is the English-translated version of 组织工程医疗产品 第25部分 动物源性生物材料DNA残留量测定法：荧光染色法.
YY/T 0606.25-2014 is the Chinese standard "Tissue engineered medical product - Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method".
Its scope clause reads: YY/T 0606 This section applies to animal biological material and its derivatives final products or intermediate products for tissue engineering Medical Spa products of animal origin scaffold matrix or scaffold can also be used for human-derived materials.
This part of the test method for the quantitative detection of residual DNA biological material of animal origin. Sample to be tested for residues in DNA The detection result in the detection sensitivity of the method of the effective portion.
Is set for each particular sample, test conditions whether co Treatment requires appropriate method validation. In addition to this standard selection methods, may adopt other equivalent method.
Implementation of this part of the user shall establish appropriate safety and health regulations, and the applicability of the provisions of the regulations. Its clauses include terms and definitions.
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Document preview — YY/T 0606.25-2014
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 3.1 Matrix
- 3.2 Bracket scaffold
- 3.3 Animal
- 3.4 Derivatives derivates
1 Scope
YY/T 0606 This section applies to animal biological material and its derivatives final products or intermediate products for tissue engineering Medical
Spa products of animal origin scaffold matrix or scaffold can also be used for human-derived materials.
This part of the test method for the quantitative detection of residual DNA biological material of animal origin. Sample to be tested for residues in DNA The detection result in the detection sensitivity of the method of the effective portion. Is set for each particular sample, test conditions whether co
Treatment requires appropriate method validation. In addition to this standard selection methods, may adopt other equivalent method.
Implementation of this part of the user shall establish appropriate safety and health regulations, and the applicability of the provisions of the regulations.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
People's Republic of China Pharmacopoeia 2010 edition three
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Matrix
Tissue-engineered medical products as the growth of cells or biomolecules, support or delivery vehicle of raw materials, which can be a polymer composition
Quality, or it may be the biological tissue extracellular matrix (Matrix) substances derived from biological origin.
3.2 Bracket scaffold
Alternative, repair or regeneration of tissue cells or biologically active factors migration, binding or transporting a support, carrier or matrix release.
Many organic compounds (biogenic substances), inorganic and polymeric substances can be used as tissue engineering scaffolds medical products.
3.3 Animal
Spine or any invertebrate [including amphibians, arthropods (eg crustaceans), birds, coral, fish, reptiles, molluscs
Matter and mammals], does not include people (Homo sapiens).
3.4 Derivatives derivates
Substance obtained by the manufacturing process from animal-derived materials. For example. hyaluronic acid, collagen, gelatin, monoclonal antibody, chitosan, white
Protein.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Cited by
- YY/T 1794-2021General technical requirements for dental collagen membrane
- YY/T 1561-2017Tissue engineering medical device products - Residual alpha-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives
- YY/T 1562-2017Tissue engineering medical device products-Biomaterial scaffolds-Guide for cell viability evaluation
- YY/T 1571-2017Tissue engineering medical device products—Sodium hyaluronate
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